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Not yet recruiting NCT07189624

Effect of Acute Endurance Exercise on the Production of FGF21 and Follistatin in Patients With Hepatocellular Carcinoma

No phase Interventional Cirrhosis With Hepatocellular Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise.
Who it may be relevant to
Registry conditions: Cirrhosis With Hepatocellular Carcinoma. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The main purpose of the study is to characterize the production of hepatokines (FGF21 and Follistatin) in response to a submaximal exercise on an ergocycle, in patients with hepatocellular carcinoma. The effect of exercise on hepatokines and metabolites production in liver cancer patients is not known. Studying this production could help to provide relevant recommendations for training programming in these patients.

Interventions

  • Other Exercise
    30-minutes exercise on a bicycle with heart rate monitor and gas exchange analyzer.

Primary outcome measures

  • Systemic hepatokines rates (FGF-21 and follistatin) [Time frame: Baseline (pre-exercise), immediately after exercise, 1 hour after the end of exercise]
Secondary outcome measures (1)
  • Muscle pain assessment [Time frame: Baseline (pre-exercise), immediately after exercise, 1 hour after the end of exercise]

Eligibility criteria

Inclusion criteria

  • Hepatocellular carcinoma developed on cirrhosis
  • Cirrhosis of any etiology, defined by a liver elasticity measurement >15kPa or a history of cirrhosis decompensation
  • Hepatocellular carcinoma with indication for treatment by immunotherapy or chemoembolization
  • Child-Pugh scores A and B7
  • WHO score ≤ 2
  • Affiliation to french national social security system

Exclusion criteria

  • Hepatic encephalopathy grade II or higher
  • Bone metastasis
  • Surgery performed within 30 days prior to inclusion visit
  • Liver transplant
  • Muscle injury within 3 months of inclusion
  • Pregnant or breast-feeding women
  • Patients under legal protection (guardianship, curatorship, safeguard of justice)
  • Participation in another clinical trial within 10 days of inclusion

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 2 centers
  • Chu Estaing Medecine Digestive Et Hepatobiliaire — Clermont-Ferrand
  • CHU de Clermont-Ferrand — Clermont-Ferrand

Identifiers

NCT: NCT07189624 · RBHP 2024 ABERGEL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗